MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-25 for NRG TRANSSEPTAL NEEDLE NRG-E-HF-71-C1 manufactured by Baylis Medical Company Inc..
[125105330]
There is no suspected device failure. The reported patient complication is an inherent risk in this type of procedure. There is no evidence to suggest the baylis medical device caused or contributed to the reported complication. However, as the baylis device was among the several devices used in the procedures, baylis medical has decided to submit this report.
Patient Sequence No: 1, Text Type: N, H10
[125105331]
The baylis nrg transseptal needle was used for transseptal puncture during a watchman left atrial appendage procedure. During the second transseptal puncture, using intracardiac echocardiography for visualization, the tip of the needle couldn't be accurately located. The physician requested radiofrequency (rf) but left atrial access was not observed. The physician adjusted the approach and was able to engage the septum. A second application of rf was applied and the septum was crossed. Soon after, hospital staff checked for an effusion and fluid could be seen. Pericardiocentesis was performed to drain blood and restore blood pressure to safe levels. There is no evidence to suggest the baylis medical device caused or contributed to the reported complication. However, as the baylis device was among the several devices used in the procedures, baylis medical has decided to submit this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9710452-2018-00039 |
| MDR Report Key | 8007080 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-09-27 |
| Date Added to Maude | 2018-10-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MEGHAL KHAKHAR |
| Manufacturer Street | 2775 MATHESON BLVD. EEAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4W 4P7 |
| Manufacturer G1 | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Street | 2775 MATHESON BLVD. EAST |
| Manufacturer City | MISSISSAUGA, ONTARIO L4W 4P7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4W 4P7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NRG TRANSSEPTAL NEEDLE |
| Generic Name | RF TRANSSEPTAL NEEDLE |
| Product Code | DXF |
| Date Received | 2018-10-25 |
| Model Number | NRG-E-HF-71-C1 |
| Catalog Number | NRG-E-HF-71-C1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAYLIS MEDICAL COMPANY INC. |
| Manufacturer Address | 5959 TRANS-CANADA HIGHWAY MONTREAL, QUEBEC H4T 1A1 CA H4T 1A1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-25 |